OLE Study for Patients With Parkinson's Disease With Dementia Enrolled in Study ANAVEX2-73-PDD-001

  • STATUS
    Recruiting
  • End date
    Oct 31, 2021
  • participants needed
    120
  • sponsor
    Anavex Life Sciences Corp.
Updated on 12 October 2020
Investigator
Rosalyn Lai, Dr
Primary Contact
KaRa MINDS (0.8 mi away) Contact
+4 other location

Summary

This is a Phase 2 open-label extension study to evaluate the effects of ANAVEX2-73 on safety and efficacy of daily treatment.

Description

This is a Phase 2 open-label extension study to evaluate the effects of ANAVEX2-73 on safety and efficacy of daily treatment.

Details
Treatment ANAVEX2-73
Clinical Study IdentifierNCT04575259
SponsorAnavex Life Sciences Corp.
Last Modified on12 October 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 50 yrs and 85 yrs?
Gender: Male or Female
Do you have Parkinson Disease Dementia?
Previous completion of participation in the ANAVEX2-73-PDD-001 study
Caregivers and subjects (or legal representative) must understand and have signed approved informed consent
Caregivers and subjects (or legal representative) must be able to understand study requirements and be willing to follow instructions
Stable regimen of anti-Parkinson's disease medications (including levodopa, dopamine agonists, MAO-B inhibitors, or the COMT inhibitor entacapone), which has been stable for at least 4 weeks prior to Baseline
Treatment with cholinesterase inhibitor (rivastigmine, donepezil and galantamine (Exelon, Aricept, or Reminyl) will be permitted, provided the dose has been stable for a minimum of 8 weeks prior to joining this study
Subjects with history of depression on antidepressant medications will be allowed if depression is controlled and they have been on a stable daily dose of the antidepressant for 8 weeks before Baseline
Contraception: Women of childbearing potential must use an acceptable method of contraception starting 4 weeks prior to study drug administration and for a minimum of 4 weeks after study completion. Otherwise, women must be postmenopausal (at least one year absence of vaginal bleeding or spotting) as confirmed by FSH greater than or equal to 40 mIU/mL or 40 IU/L or be surgically sterile
Men with a potentially fertile partner must have had a vasectomy or be willing to use an acceptable method of contraception for the duration of the study and for 3 months after study drug discontinuation

Exclusion Criteria

History of any significant neurologic or psychiatric disorder other than PD that can contribute to cognitive impairment
Any other condition or clinically significant abnormal findings on the physical or neurological examination, medical and psychiatric history, at screening or at baseline that, in the opinion of the Investigator, would make the subject unsuitable for the study
Potential symptomatic causes of cognitive impairment including but not limited to
abnormal thyroid function test at screening (TSH)
abnormal B12 level at screening
MRI findings (by history) pointing to a potential symptomatic cause of cognitive dysfunction, including significant vascular changes, or communicating hydrocephalus
Treatment with memantine or amantadine. If appropriate the drugs can be discontinued for a minimum of 4 weeks prior to enrollment
History of depression as measured by Beck Depression Inventory score >17 at screening
Treatment with any other investigational drug or device within 4 weeks prior to screening
Smoking > 1 pack of cigarettes per day (as assessed for the 4 weeks prior to screening)
Women who are pregnant or lactating
Known allergy or sensitivity to ANAVEX2-73 or any of its components
Suicidal ideation on the Columbia Suicide Severity Rating Scale (C-SSRS) of type 4 or type 5, or any suicidal behavior, in the past 6 months. Type 4 indicates active suicidal ideation with some intent to act, without a specific plan. Type 5 indicates active suicidal ideation with a specific plan and intent
Use of centrally acting anticholinergic drugs during the 4 weeks before enrollment
Medications used for overactive bladder will be allowed provided that the regimen has been stable 4 weeks prior to enrollment
Treatment with any dopamine receptor blocking medications with the exception of low dose quetiapine (50 mg/day). Pimavanserin (34 mg/day) will be allowed
History of neurosurgical intervention (e.g., deep brain stimulation) for PD
Unpredictable motor fluctuations that would interfere with administering cognitive assessments in the ON state
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Step 2 Get screened

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Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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